EFLM Biological Varation Database : BIVAC Minimum Data Set for Prostate specific antigen (PSA)

Prostate specific antigen (PSA) - free

Reference

Nixon RG, Lilly JD, Liedtke RJ, Batjer JD, 1997, Arch Pathol Lab Med, 121(4), 385-91 , Variation of free and total prostate-specific antigen levels: the effect on the percent free/total prostate-specific antigen

Scoring

Total Score

C_7,8,10,13

Parameter	Score
1. Scale	A
2. Study Population	A
3. Samples	A
4. Measurand	A
5. Pre-Analytical	A
6. Replicate Analysis	B
7. Steady State	C
8. Outlier Analysis	C
9. Normality	B
10. Variance Homogeneity	C
11. ANOVA	B
12. CI	A
13. No of Results	C
14. Concentrations	A
15. Total Score	C_7,8,10,13
Comment

Item Details

Parameter	Score
Matrix	Serum
Measurand	Prostate specific antigen (PSA) - free
Unit	ng / mL
Overall Analytical Principle Method	Chemiluminescence
Number of Subjects	9
Number of Subjects included in BV estimation	9
Ethinicity	Unknown
Age Mean / Median	60.0
Age Min	48.0
Age Max	69.0
Age SD
Number of Males	9
Number of Females	0
State of Well Being	Non-healthy (excl pregnant)
Study Duration Length	2
Study Duration Units	Week
Sampling Intervals, e.g. X sample(s) per Interval Unit	2
Interval Units	Day
Sampling Times	Start Time: End Time:
Number of Samples	5
Average Number of Samples Used for BV Estimation	5.0
Average Number of Replicates	1.0
Estimates of CVi	13.0
Calculated Confidence Intervals of CVi	Lower: 0.41, Upper: 17.38
Estimates of CVg
Calculated Confidence Intervals of CVg	Lower: , Upper:
Analytical CV	5.0
Calculated Confidence Intervals of Analytical CV	Lower: 3.00, Upper: 14.37
Measurand Mean	1.17
Measurand Min	0.24
Measurand Max	2.1
Measurand SD

Coding

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